Mixed data for AZ, BMS diabetes drug in new study

Wed Oct 21, 2009 8:36am EDT

* Drug cuts blood sugar levels but linked to more infections

* Dapagliflozin may be first in new drug class to hit market

LONDON, Oct 21 (Reuters) - An experimental diabetes drug from AstraZeneca (AZN.L) and Bristol-Myers Squibb (BMY.N) has delivered mixed results in a second late-stage clinical study, by reducing blood sugar levels but also raising infection rates.

Data being presented at the International Diabetes Federation meeting in Montreal this week showed dapagliflozin lowered levels of HbA1c -- a common measure of blood glucose -- by 0.7 percentage points more than placebo but was associated with more urinary tract and genital infections.

A study abstract also showed, somewhat disappointingly, no significant difference in weight loss among patients taking the new drug in the 24-week test.

The new study is the second in a series of 10 Phase III trials that the companies are conducting. Results of the first were presented earlier this month at a diabetes meeting in Vienna. [ID:nL1361836]

Dapagliflozin is a member of a class of drugs known as SGLT2 inhibitors, designed to block reabsorption of glucose. If approved, it could be the first such drug to reach the market, and Astra and Bristol have said they could file for approval in late 2010 or early 2011.

Morgan Stanley analyst Andrew Baum said the new data showed better efficacy but worse safety than the Phase III results presented in Vienna, where dapagliflozin was tested in combination with the older drug metformin.

Baum continues to see a 50 percent chance of the drug being launched in 2011 and forecasts risk-adjusted sales of $300 million in 2015. (Reporting by Ben Hirschler, editing by Will Waterman)